Product

Ready-to-Use Calcium Phosphate Cement

VELOX is a ready-to-use, injectable bone substitute cement supplied in a prefilled syringe. It is intended for filling or reconstruction of non-load-bearing bone defects, or bone defects stabilized by appropriate means, and can also be used to augment temporary osteosynthesis fixation.

2. Product Overview & Material Behavior

PRODUCT OVERVIEW

VELOX is a calcium phosphate bone substitute cement supplied as a paste in a syringe. No preparation is required before injection, allowing the material to be applied directly from the syringe. VELOX sets only in a humid environment, so there is no time restriction during application.

AFTER SETTING

After setting, VELOX forms a calcium-deficient hydroxyapatite bone substitute, the major mineral constituent of bone, and is remodeled into bone over time.

3. Key Benefits & Intended Use

KEY BENEFITS

• Ready to use — no preparation required before application.
• Supplied in a 3 cc prefilled syringe.
• Injectable paste for direct application to the defect site.
• No time restriction during application, as VELOX sets only in a humid environment.
• Supports temporary osteosynthesis fixation as an augmentation material.
• Can be applied arthroscopically.
• Reduced risk of migration from the application site.
• Forms a calcium-deficient hydroxyapatite bone substitute after setting.

INTENDED USE

VELOX is intended for filling or reconstruction of non-load-bearing bone defects, or for filling bone defects that are stabilized by appropriate means.

Examples of Bone Voids

• Trauma (accidents, falls, etc.): e.g. metaphyseal defect fractures, and filling of bone defects after fixation, removal or revision of osteosynthetic implants.
• Reconstruction (restoring function and form of bone): e.g. after removal of cancerous tissue.
• Correction: congenital defects.

4. Setting & Strength — “Time Matters”

Time Matters

VELOX sets progressively after application:

• 10 minutes: dimensional stability is achieved.
• 24 hours: compressive strength is comparable to cancellous bone.
• 7 days: X-ray diffraction data show similarity in chemical composition and crystalline structure between VELOX and human bone.

Compressive strength increases steadily after setting begins, reaching an ultimate compressive strength of approximately 45 MPa after four days, depending on the volume of VELOX applied and vascular supply.

5. Composition & Presentation

Composition

• Calcium Carbonate
• Calcium Hydrogenphosphate
• α-Tricalcium Phosphate
• Precipitated Hydroxyapatite
• Non-Hydrous Carrier Liquid

Presentation

• Ready-to-use injectable paste.
• 3 cc prefilled syringe.
• No preparation required prior to application.

6. Scientific / Preclinical Evidence

PRECLINICAL EVIDENCE

A histological evaluation of a ready-to-use, self-setting calcium phosphate bone substitute cement was performed in an adult sheep implantation model (Dr. Berthold Nies, InnoTERE GmbH, in collaboration with the Laboratory for Experimental Traumasurgery, University Hospital of Giessen and Marburg, 24 April 2013). VELOX was injected into created critical-size drill-hole defects in the distal femur and proximal tibia.

Histological examinations at 4 weeks, 3 months, 6 months and 18 months showed implant material remodeling and progressive bone integration. Newly formed bone penetrated deep into the implant at defect sites, and by 6 and 18 months the implant was almost completely integrated into lamellar bone, with no decline in osseointegration observed over the 18-month period.